Evaluation of the Motus Gl CleanUp System During Screening Colonoscopy

NCT ID: NCT02161549

Last Updated: 2017-09-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 71 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2013-10-31

Brief Summary

Motus Gl is developing a single-use device that attaches to a standard colonoscope, thereby integrating colon cleansing, screening and treatment into one procedure.

The device creates turbulence within the colon using water jets. The colon's fecal fluids are evacuated by the system.

Detailed Description

63 eligible subjects who are allocated for a diagnostic screening colonoscopy were enrolled in the study. The assignment of the level of the bowel preparation agent was according to the physician decision. Following preparation, enrolled subjects were intubated and cleansed using a standard colonoscope with the Motus GI CleanUp device attached to it. At the end of the procedure, subjects were followed through discharge and at 48 hours post procedure for occurrence of adverse events.

40 subjects were enrolled under protocol Rev 1.0 used Motus GI CleanUp System Rev 1.0 31 subjects were enrolled under protocol Rev 2 used Motus GI CleanUp System Rev 1.5, due to improvement made to the study device including the following:

1. One head that irrigates and evacuates instead of two heads

2. Elimination of the grinding mechanism and the motor to reduce the pipes' diameters while keeping the same flow rate.

3. System adjustment to the above changes including updated software version.

Conditions

CRC

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Colonoscopy with MotusGi CleanUp System Rev 1.0

subjects indicated for colonoscopy procedure with CleanUp System Rev 1.0 , enrolled under protocol Rev 1.0

Motus Gl CleanUp System

Intervention Type: DEVICE

Colonoscopy with MotusGi CleanUp System Rev 1.5

subjects indicated for colonoscopy procedure with CleanUp System Rev 1.5 , enrolled under protocol Rev 2.0

Motus Gl CleanUp System

Intervention Type: DEVICE

Interventions

Motus Gl CleanUp System

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Subjects in the age range of 50-69 years
• Subjects who are considered for routine screening colonoscopy
• Subjects with BMI within the range of 18.5-30
• Subject is willing to sign informed consent form

Exclusion Criteria

• History of G diseases or history of Colorectal cancer (personal or family)
• Previous major abdominal surgeries
• Medical status ASA grater or equal to 3
• Acute Gl symptoms, such as bleeding, unexplained weight loss, inflammatory bowel disease (lBD).
• Patients taking anticoagulants (e.g., Coumadin, Heparin, Clopidrogrel)
• Life-threatening condition
• Subjects who are unable or unwilling to cooperate with study procedures
• Severe Diverticula

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Motus GI Medical Technologies Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinica San Rafael

Cadiz, , Spain

Countries

Spain

Other Identifiers

CP-MCU-SP-1211

Identifier Type: -

Identifier Source: org_study_id